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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device has supplements. The device description may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
Classification Nameautomated breast ultrasound
ApplicantU-SYSTEMS, INC.
PMA NumberP110006
Date Received02/11/2011
Decision Date09/18/2012
Product Code
PAA[ Registered Establishments with PAA ]
Docket Number 12M-1011
Notice Date 09/25/2012
Advisory Committee Radiology
Clinical Trials NCT00816530
Expedited Review Granted? No
Combination Product No
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
Recalls CDRH Recalls
Approval Order Statement 
Approval for the somo-v: automated breast ultrasound system (abus). This device is indicated as an adjunct to mammography for breast cancer screening in asymptomatic women for whom screening mammography findings are normal or benign (bi-rads assessment category 1 or 2), with dense breast parenchyma (bi-rads composition/density 3 or 4) and have not had previous clinical breast intervention. The device is intended to increase breast cancer detection in the described patient population.
Approval Order Approval Order
Supplements: S001 S002 S003 S004 S005